A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 40
- 主要终点
- Number of Participants Remaining on Spironolactone at Week 12
研究概览
简要总结
The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).
详细描述
Approximately 290 eligible participants with [chronic kidney disease (CKD) on stable doses of medication] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day.
All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period).
The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Taking at least three medications for blood pressure (one a diuretic)
- •Uncontrolled high blood pressure
- •Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2
- •Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)
排除标准
- •History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)
- •Inability to measure BP
- •Not taking high blood pressure medications as prescribed medications
- •Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis
- •Renal transplant
- •History of cancer within past 12 months
- •Recent cardiovascular event with last 3 months
- •Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)
- •Inability to take study medication
- •Alcoholism
研究组 & 干预措施
Group 1 - Patiromer
spironolactone + blinded patiromer
干预措施: Patiromer (Drug)
Group 1 - Patiromer
spironolactone + blinded patiromer
干预措施: Spironolactone (Drug)
Group 2 - Placebo
spironolactone + blinded placebo
干预措施: Placebo (Drug)
Group 2 - Placebo
spironolactone + blinded placebo
干预措施: Spironolactone (Drug)
结局指标
主要结局
Number of Participants Remaining on Spironolactone at Week 12
时间窗: At week 12
The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.
次要结局
- Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications(From baseline to Week 12)